A Study Of PF-05175157 In Healthy Volunteers

NCT01274663

Last updated date
Study Location
Pfizer Investigational Site
South Miami, Florida, 33143, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 years (inclusive).

- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.

- In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.

- Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant hematological, renal, endocrine,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic
disease (including drug allergies).


- Evidence or history of any chronic ongoing or current pulmonary disease.


- History of smoking in the past 5 years or history or evidence of habitual use of other
(non-smoked) tobacco or nicotine-containing products within 3 months of Screening or
positive cotinine test at Screening or Day 0.


- Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye
symptoms or retinal/optic nerve disease.


- Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular
inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including
Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular
lubricants, or use of contact lenses.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-05175157 In Healthy Volunteers
Official Title  ICMJE A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-05175157 After Administration Of Single Escalating Oral Doses Under Fasted And Fed Conditions In Healthy Volunteers
Brief Summary The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: PF-05175157 or Placebo
    One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
  • Drug: PF-05175157 or Placebo
    One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Study Arms  ICMJE
  • Experimental: 10 mg PF-05175157 or Placebo
    Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
    Intervention: Drug: PF-05175157 or Placebo
  • Experimental: 30 mg PF-05175157 or Placebo
    Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
    Intervention: Drug: PF-05175157 or Placebo
  • Experimental: 100 mg PF-05175157 or Placebo
    Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
    Intervention: Drug: PF-05175157 or Placebo
  • Experimental: 300 mg PF-05175157 or Placebo
    Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
    Intervention: Drug: PF-05175157 or Placebo
  • Experimental: 600 mg PF-05175157 or Placebo
    Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
    Intervention: Drug: PF-05175157 or Placebo
  • Experimental: 800 mg PF-05175157 or Placebo
    Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
    Intervention: Drug: PF-05175157 or Placebo
  • Experimental: xxx mg PF-05175157 or Placebo
    Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
    Intervention: Drug: PF-05175157 or Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2011)
63
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 years (inclusive).
  • Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
  • In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
  • Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
  • Evidence or history of any chronic ongoing or current pulmonary disease.
  • History of smoking in the past 5 years or history or evidence of habitual use of other (non-smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0.
  • Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
  • Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01274663
Other Study ID Numbers  ICMJE B1731001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP